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IWR

4 FDA 510(k) clearances · Product code

FDA profile

Official device name
Holder, Syringe, Lead
Device class
Class I (low risk)
Regulation
21 CFR 892.6500
Medical specialty
Radiology
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RecordFirmDate
ALL-VUE ULTRA-LITE THIN WALL SYRINGE SHIELD (K934549)Victoreen, Inc.1994-02-19
LEAD GLASS SHIELDS (K872656)Viox Corp.1987-07-16
DUFFY BOLUS INJECTOR (K863936)Viox Corp.1987-01-06
TUNGSTEN SYRINGE SHIELD (K811688)Medi-Physics Inc. Dba Nycomed Amersham Imaging1981-07-02

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Every clearance here is in the API, with alerts when new ones post.